Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ASCORBIC ACID

Available from:

Pascoe Pharmazeutische Präparate GmbH Schiffenberger Weg 55 35394 Giessen , Germany

ATC code:

A11GA01

INN (International Name):

ASCORBIC ACID 7.5 g

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

ASCORBIC ACID 7.5 g

Prescription type:

POM

Therapeutic area:

VITAMINS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-11-04

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ASCORBIC ACID PASCOE 150 MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION
/ INFUSION
ascorbic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for
injection / infusion
_ _
is and
what it is used for
2.
What you need to know before you use Ascorbic Acid Pascoe 150 mg/ml
Concentrate for
solution for injection / infusion
3.
How to use Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for
injection / infusion
4.
Possible side effects
5.
How to store Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution
for injection / infusion
6.
Contents of the pack and other information
1.
WHAT ASCORBIC ACID PASCOE 150 MG/ML CONCENTRATE FOR SOLUTION FOR
INJECTION / INFUSION_ _IS
AND WHAT IT IS USED FOR
Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection
/ infusion is intended for the
treatment of clinical vitamin C deficiency states not amenable to
dietary supply or intake of vitamin C
preparations.
Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection
/ infusion contains the essential
active substance ascorbic acid (vitamin C) that cannot be produced
internally by the human body.
Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection
/ infusion is indicated in
adults.
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2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ASCORBIC ACID PASCOE 150 MG/ML
CONCENTRATE FOR
SOLUTION FOR INJECTION / INFUSION
DO NOT USE ASCORBIC ACID PASCOE 150 MG/ML CONCENTRAT

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection
/ infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial with 50 ml concentrate for solution for injection/infusion
contains: 7.5 g ascorbic acid
Excipient with known effect:
Sodium hydrogen carbonate (50 ml of the concentrate contains 972 mg
sodium).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for injection/infusion.
Clear, light yellow solution.
The pH ranges from 6.2 to 7.0.
The osmolality is 1500-1700 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of clinical vitamin C deficiency states not amenable to
dietary supply or oral replacement
therapy.
Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection
/ infusion is indicated in
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_ _
_Adults: _
The usual dose is 0.5 to 1.0 g ascorbic acid (corresponding to 3.3 –
6.7 ml concentrate). Severe trauma
or surgery can require daily dosages of at least 3 g ascorbic acid to
restore normal plasma levels.
Depending on the disease situation, up to 7.5 g ascorbic acid (50 ml
concentrate) per day may be used
for infusion.
_ _
_Paediatric population: _
Children under 12 years of age should not receive more than 5-7 mg
ascorbic acid/kg body weight per
day. High doses of Ascorbic Acid Pascoe 150 mg/ml Concentrate for
solution for injection / infusion
are contraindicated in children under 12 years (see section 4.3). No
data are available on the use of
Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection
/ infusion in adolescents.
Method of administration
For slow intravenous injection or infusion after dilution.
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For instructions on dilution prior to administration, see section 6.6.
The injection/infusion therapy must be performed by a physician.
The duration of use depends on the course of the illness and the
results of laboratory tests.
_Inst